Children with attention-deficit hyperactivity disorder demonstrated
greater improvement in symptoms such as hyperactivity, impulsivity, and
attention with Concerta than with atomoxetine, according to interim
results from the first direct comparison of the two treatments.

Symptom improvement was significantly greater with Concerta than
with atomoxetine (Strattera) at each consecutive week of the 3-week
study. The magnitude of the difference increased over time.

Stimulant medications such as methylphenidate HCI have been
considered the best treatment for ADHD for more than 40 years, but the
recent introduction of nonstimulant treatments such as atomoxetine and
extended-release formulations like the OROS (osmotic-release oral
system) extended-release system used in the once-daily methylphenidate
have brought new treatment options to clinicians. The prospective,
randomized, open-label study of more than 1,300 children was conducted
by more than 300 physicians across the country. It was sponsored by
McNeil Pharmaceuticals, the manufacturer of Concerta.

In another study, investigators found that children with ADHD who
took once-daily, extended release formulations of Concerta saw greater
improvements during the school day than those who took that formulation
of Metadate CD. The treatment results, however, were similar between the
two groups in the afternoon.

In this multisite study, 184 children aged 6-12 years who had been
diagnosed with ADHD were randomized to receive near-equal doses of
Metadate, Concerta, or placebo once daily in the morning for 1 week.

On day 7, the children attended a laboratory school where trained
observers on attention and deportment rated them over a 12-hour period
(Pediatrics [online] 113[3], 2004:
http://pediatrics.aappublications.org/cgi/content/full/113/3/e206).

The investigators found that the behavioral effects of Metadate CD
were greater than those for Concerta across the day. These findings can
help to "guide the selection of the most appropriate once-daily
stimulant treatment for the child with ADHD," the investigators
said. Celltech Pharmaceuticals Inc., which markets Metadate CD, funded
that study.

Jason E. Kemner of McNeil Pharmaceuticals said the most interesting
aspect of the Concerta vs. Straterra study is that differences between
the two products were seen at the first evaluation, and as the study
went along, those differences got larger.

Subjects in the Formal Observation of Concerta Versus Strattera
(FOCUS) study were newly diagnosed or inadequately managed on current
treatment and had an investigator Attention-Deficit/Hyperactivity
Disorder Rating Scale (ADHD RS) score of 24 and a Clinical Global
Impressions-Severity of Illness (CGI-S) score of 3.

To date, 422 children have been randomized to methylphenidate HCI
and 229 to atomoxetine. Medication was initiated and titrated according
to each product's package insert. ADHD-RS scores at baseline were
similar in the methylphenidate HCI and atomoxetine groups (39.77 vs.
38.87, respectively). The 3-week duration of the study was not a
limitation and is a relatively common length for an ADHD trial, said Mr.
Kemner, McNeil's manager of outcomes research and health economics.

The results confirm the general impressions of many clinicians
about stimulants versus non-stimulants. Dr. David Goodman of the
department of psychiatry and behavioral sciences at Johns Hopkins
University, Baltimore, said in an interview.

"I'm not sure any clinician is going to be surprised by
the outcome. It confirms what they see in practice." Dr. Goodman
said. "If you want a quick response and improvement in symptoms for
ADHD, then stimulant medications like Concerta are demonstrated
effective consistently in research."

BY PATRICE G. W. NORTON

Contributing Writer

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